In the development of Semisolids products, IIG Clearance plays a crucial role in ensuring that the inactive ingredients used are within the acceptable limits established by the FDA, which is essential for maintaining product safety, efficacy, and patient tolerance.

        The IIG Clearance template helps ensure that all inactive ingredients in the formulation are accurately assessed against FDA standards. This ensures that the formulation does not exceed established safety thresholds, reducing the risk of regulatory setbacks and potential adverse effects.

        This template ensures that all inactive ingredients’ IIG evaluations are conducted and meet IIG criteria which support a smoother regulatory review, reducing the likelihood of deficiencies and facilitating a more efficient approval process.

       The Maximum Daily Dose (MDD) is a key parameter in pharmaceutical development, ensuring patient safety and regulatory compliance. It is determined using information from the Reference Listed Drug (RLD) package insert available on Drugs@FDA , the Orange Book, or DailyMed